TEVA-DABIGATRAN CAPSULE
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
26-04-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
B01AE07
INN (Alþjóðlegt nafn):
DABIGATRAN ETEXILATE
Skammtar:
150MG
Lyfjaform:
CAPSULE
Samsetning:
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
60
Gerð lyfseðils:
Prescription
Lækningarsvæði:
DIRECT THROMBIN INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0152467003; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2018-02-19
Vara einkenni
1
PRODUCT MONOGRAPH
PR
TEVA-DABIGATRAN
Dabigatran Etexilate
Capsule
s
Capsules 75 mg and 150 mg Dabigatran Etexilate,
(as Dabigatran Etexilate Me
silate)
Anticoagulant
Teva Canada Limited.
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
Date of Preparation
APRIL 26, 2017
Control Number:
184807
2
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
......................................................................................................
3
WARNINGS AND PRECAUTIONS
....................................................................................
4
ADVERSE REACTIONS
.....................................................................................................
11
DRUG
INTERACTIONS.....................................................................................................
21
DOSAGE AND ADMINISTRATION
................................................................................
27
OVERDOSAGE
....................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 34
STORAGE AND STABILITY
............................................................................................
38
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................. 38
PART II: SCIENTIFIC INFORMATION
....................................................................................
40
PHARMACEUTICAL INFORMATION
...........................................................................
40
CLINICAL
TRIALS.............................................................................................................
42
DETAILED PHARMACOLOGY
............
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